DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 28-30, 32, 34, and 43 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In regards to claim 28, the limitations “wherein said receiving comprises receiving at least two signals, where said at least two signals are different from each other in at least one parameter; and wherein said method further comprises comparing said at least two received signals as part of said analyzing” are vague. Claim 28 is an apparatus claim with no “receiving” step or “method” to be “further comprising” any steps. It is unclear if or how these limitations limit any structure actually set forth in the claim.
The remaining claims are rejected by virtue of their dependency.
Allowable Subject Matter
Claims 28-30, 32, 34, and 43 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claims 1-3, 5-7, 11, 19, 20, 22-26 and 49-53 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: the closest prior art is to Heldman et al. (US 2014/0074180, hereinafter “Heldman”). Although Heldman does disclose a stimulation optimization algorithm that sets stimulation parameters, and that, in the prior art, “[t]hese parameters are initially set during implantation surgery separately and independently for each DBS lead that is implanted, and are then further fined-tuned in the outpatient clinic or in a doctor's office following surgery to maximize therapeutic benefit and minimize undesirable stimulation-induced side effects” (par. 0007) and “is normally completed during DBS lead placement surgery and subsequent programming sessions to evaluate performance while a clinician qualitatively assesses symptoms” (par. 0011), Heldman does not, alone or in combination with the remaining prior art, disclose or fairly render unpatentable the concept of analyzing the received signals to quantitatively assess at least one treatment side effect and at least one symptomatic effect, and selecting a set of treatment parameter values based on the quantitative assessment received during lead implantation surgery wherein receiving comprises receiving at least two signals different from each other in at least one parameter and comparing the at least two signals as part of the analyzing, in combination with the remaining claim elements. For instance, Heldman discloses an optimization routine using symptomatic effects and side effects in par. 0108, but this is performed “for the first postoperative programming session” and there is no indication that this entails comparing two received signals different from each other in at least one parameter received during the electrode lead implantation surgery.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL W KAHELIN whose telephone number is (571)272-8688. The examiner can normally be reached M-F, 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at (571)270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792
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